BD FACS¿ LYSE WASH ASSISTANT
Received Aug 10, 2023 · Event occurred Jul 27, 2023
Report 2916837-2023-00164 · MDR key 17499747
Device
Generic name
Station, Pipetting Diluting Clinical Use
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
337146
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E.1. INITIAL REPORTER PHONE#:(B)(6). D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER WAS OBSERVED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTER: CARRY-OVER SOMETIMES OCCURS AFTER MEASURING LARGE PATHOLOGICAL POPULATIONS.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: REPORTING OFFICE AND CONTACT: (B)(6) MANUFACTURING LOCATION: BECTON DICKINSON AND COMPANY BD BIOSCIENCES- SAN JOSE. MANUFACTURING SITE CONTACT: (B)(4). H.6: BASED ON THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE DIRTY NEEDLE AND OVER NEEDLE. THE FSR CLEANED THE NEEDLE AND OVER NEEDLE AND AFTER SUBSEQUENT TRIAL RUNS WITH SAMPLES, THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO PATIENTS WERE HARMED FROM ANY ERRONEOUS RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER WAS OBSERVED ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTER: CARRY-OVER SOMETIMES OCCURS AFTER MEASURING LARGE PATHOLOGICAL POPULATIONS.